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Confocal Optical Imaging
FDA product code OWN · Class 2 · Gastroenterology, Urology
223
Registered devices
1,525
Adverse events
4
Recalls
62
510(k) clearances
Devices with this code
NA — SCHÖLLY FIBEROPTIC GmbHVS3-IR — VISIONSENSE LTD.NA — SCHÖLLY FIBEROPTIC GmbHVS3 Iridium — VISIONSENSE LTD.AIM (Advanced Imaging Modality) — STRYKER CORPORATIONVS3-IR — VISIONSENSE LTD.NA — SCHÖLLY FIBEROPTIC GmbHCholangioFlex™ N — MAUNA KEA TECHNOLOGIESAQ-Flex™ 19-C — MAUNA KEA TECHNOLOGIESNA — SCHÖLLY FIBEROPTIC GmbHNA — SCHÖLLY FIBEROPTIC GmbHpde-neo — HAMAMATSU PHOTONICS K.K.VS3-IR — VISIONSENSE LTD.NA — SCHÖLLY FIBEROPTIC GmbHNA — SCHÖLLY FIBEROPTIC GmbHAveoFlex™-C — MAUNA KEA TECHNOLOGIESCystoFlex™ R N — MAUNA KEA TECHNOLOGIESLight Cable — Smartsurgn Inc.NA — Karl Storz GmbH & Co. KGNA — SCHÖLLY FIBEROPTIC GmbHConfocal Microprobe Imaging System — Wuxi Hisky Medical Technologies Co.,Ltd.EyeRSurgN — Smartsurgn Inc.GastroFlex™UHD-C — MAUNA KEA TECHNOLOGIESVS3-IR — VISIONSENSE LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-24 | Olympus Corporation of the Americas | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
| 2022-10-17 | Visionsense, Ltd. | XXX |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
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